Department: Azzur Cleanrooms On Demand Burlington LLC
The CQV Engineer Lead is responsible for providing Engineering and Operational support to the installation, commissioning, validation, operation, and maintenance of the equipment and facilities at Azzur Cleanrooms On Demand (COD) as a full-time employee (40 hrs per week on average).
Provide Engineering and Facility support to the Operations Team, including:
- Provide engineering support to existing and/or new equipment and facility assets throughout their life cycle. Typical activities include:
- Equipment validation/qualification, including generation and execution of IQ, OQ, PQ Protocols
- Equipment maintenance
- Equipment calibration
- User Requirements Specifications
- Change Controls
- Collect, analyze and report data
- Support Customer Activities related to cleanroom operations, performance, and maintenance.
- Support Environmental and Utility Monitoring Activities.
- Create and/or revise Standard Operating Procedures (SOPs)
- Participate in, support, and/or lead Quality Investigations, Root Cause Analysis, and CAPA Implementation
- Participate in, support, and/or lead Risk Assessments, including FMEAs
- Assist with materials management activities, including shipping, receiving, material restocking, and material transfer.
- Assist with various facility activities, including site and asset maintenance
- Assist with scheduling, operations management, and enforcement of facility regulations
Basic Qualifications & Position Requirements
- Bachelor Degrees
- Bachelor’s Degree with a study concentration in a scientific discipline or engineering.
- A minimum of 7-10 years of experience with increasing responsibility within biopharma/med device industry.
- Experience with capital projects and budget management, financing, and related activities
- Experience with facility, utilities, equipment, and system (FUSE) qualification
- Experience working in a cGMP environment of the Pharmaceutical or Medical Device industry.
- Facilities, Utilities, Equipment, and Manufacturing systems
- Microsoft Word, Excel, Powerpoint
- Solid knowledge of compliance requirements for computerized systems in the FDA-regulated environment, including intimate knowledge of 21 CFR Part 11 and Annex 11
- Working knowledge of AutoCAD systems
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.